Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/04—Anorexiants; Antiobesity agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/06—Antihyperlipidemics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P3/00—Drugs for disorders of the metabolism
  • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P37/00—Drugs for immunological or allergic disorders

Definitions

• the invention relates, in particular to the use of Nerium oleander composition for the control of high blood glucose levels, the control of cholesterol and triglyceride levels and the modulation of HDL-LDL ratios seen in patients with Type Il diabetes.
• Oleander (lat. Nerium oleander, NO) of the dogbane (Apocynaceae) family grows along the whole Mediterranean coast starting in southern Portugal in the west, and in Iran, and in streambeds of the Western and Southern Anatolia.
• Oleander is a plant which has a historical use since the antique ages up till our day.
• Oleander which has a limited folkloric use in the countries of the Mediterranean basin where it grows, is basically a plant which has distinct toxic properties.
• the fruit of oleander which flowers in summer and has a long flowering period, has a horse bean shape. Because it is poisonous, it is dangerous for humans and animals; it is also grown as an ornamental plant.
• Phase I clinical tests for NO which was brought to the agenda approximately 15 years ago with its use in the treatment of cancer by Dr. Ziya Ozel, are currently ongoing in the USA ( 5 ).
• polysaccharide In the water extract of shredded leaves of NO, there is 2.3 % polysaccharide; 67 % of the polysaccharide in the composition comprises galacturonic acid, rhamnose, arabinose, and galactose ( 8 ).
• NO has a potential of positive inotropic effect on human and animal heart.
• This effect of oleander cardenolides is similar to the Na + K + /ATP'ase inhibition in plasmalemma, as with classical digital glycosides, in terms of its physiological effect pattern.
• oleander and digital cardenolides differ in terms of their toxicities and extra- cardiac effects ( 9 ).
• the basic cardiac glycosides found in the composition of AnvirzelTM are oleandrine, odorside, neritaloside and aglycone oleandrigenin.
• AnvirzelTM sterile filtered lyophilized hot water extract of NO
• oleadrine is rapidly absorbed (C max 20 min)
• the elimination phase half-life is (tv 2 ⁇ ) 2.3 ⁇ 0.5 hours
• oral absorbrion ratio is at the level of 30 %.
• the liver level of oleadrine subsequent to its IV administration is approximately twice that of the heart and kidney tissues.
• the lethal dose (4000 mg/kg bw) has caused myocardial electrical activities which resulted in heart arrest ( 21 ).
• single dosage (1 and 0.25 mg/kg bw) and a daily (0.06 g/kg bw) NO administration were studied in Nadji sheeps; and restlessness, mastication, dyspnea, gas accumulation in rumen, ataxia in movement and paresis of muscles; and death after 4-24 hours were determined ( 22 ).
• Hemorrhage, cyanotic lungs, emphysema, catarrhal abomasitis and enteritis were noted by autopsy of dead animals.
• Diabetes is a widespread disease as a public health issue. In Europe, as well, approximately 1-2% of the population has diabetes. This ratio is 3-8% in the USA. While its worldwide prevalence is 100 million, it is estimated that this number shall double in the next 10-15 years. Diabetes is diagnosed with the presence of chronic hyperglycemia. Classical symptoms of the disease are polyuria, polydipsia, polyphagia and high venous plasma glucose along with weight loss. Diagnosis may be made in the presence of explained symptoms without requiring further examination. It is possible to have an idea of the history of blood glucose levels with HbAIc measurements.
• the starting point of treatment is the arrangements in diet and lifestyle. Diet is important in reducing body weight, lowering blood glucose concentration, increasing insulin sensitivity and reducing cardiovascular risk factors such as abnormal lipid profile and hypertension.
• Another object of the invention is to; enable its use, as supportive treatment in patients who have type Il diabetes, for the purpose of keeping lipid profile and blood glucose under control.
• Another object of the invention is to; offer a low cost solution in the treatment of the disease.
• Nerium oleander extract in the prevention of loss of body weight in patients with Type Il diabetes.
• FIG. 13 Fasting blood ALP levels obtained in the groups at the end of the experimental period (SK: Healthy rat, Normal diet; KZ10: Healthy rat, Normal diet, 10 ml NO extract; YD: Healthy rat; High fat diet (YYD), Z01 : Diabetic rat, YYD, 0.1 ml NO extract; Z1 : Diabetic rat, YYD, 1 ml NO extract; Z10: Diabetic rat, YYD, 10 ml NO extract; DK: Diabetic rat, YYD; GK: Glibenclamide (0.6 mg/kg, bw), Diabetic rat, YYD; AT: Atorvastatin (25 mg/kg, bw), Diabetic rat, YYD; FF: Fenofibrate (30 mg/kg, bw), Diabetic rat, YYD).
• SK Healthy rat, Normal diet
• KZ10 Healthy rat, Normal diet, 10
• Negative Control Rats with the experimental Type Il diabetes model formed were used. The animals were not subjected to any process. They were fed with the high fat diet throughout the duration of the experiment.
• Nerium oleander 1ml Rats with the experimental Type Il diabetes model formed were used. The animals were administered, once a day by gavage, the lyophilized material corresponding to 1 ml of the original oleander extract by diluting with 0.5 ml of physiological saline.
• the subjects in all test groups were euthanized under general anesthesia subsequent to the final sampling time after the experiment with a duration of three months. Liver, muscle, fat tissue, pancreas and blood samples were taken and kept under required conditions. Studies relating to insulin, leptin and IL-1 in the blood samples taken, and relating to caspase-3, tissue cytokine level and tissue mRNA expressions in the tissue samples taken are still ongoing.

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Citations (5)

• 2009
  • 2009-01-15 TR TR2009/00312A patent/TR200900312A2/tr unknown
  • 2009-02-03 WO PCT/TR2009/000013 patent/WO2010082906A1/en active Application Filing

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